Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis (INTEGUMENT 3)

Arcutis Biotherapeutics

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis; Atopic Dermatitis (Eczema); Atopic Dermatitis (AD)

Treatments: Drug: Vehicle Cream; Drug: Roflumilast Cream 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT07916480

ARQ-151-323

Details and patient eligibility

About

This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.

Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.

Full description

This Phase 3, multicenter, randomized, double-blind, vehicle-controlled study is designed to evaluate the efficacy, safety, and tolerability of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.

Approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis will be randomized in a 2:1 ratio to receive either roflumilast cream 0.3% or matching vehicle cream once daily for 4 weeks during the double-blind treatment period.

The primary objective of the study is to evaluate the efficacy of roflumilast cream 0.3% compared with vehicle cream at Week 4. Secondary objectives include evaluation of additional efficacy measures related to the signs and symptoms of atopic dermatitis.

Participants who complete the double-blind treatment period will be eligible to enter a 48-week open-label extension period, during which all participants will receive once-daily roflumilast cream 0.3%. The open-label extension is designed to evaluate the long-term safety, tolerability, and efficacy of roflumilast cream 0.3% through Week 52.

Safety assessments will include adverse events, local tolerability, clinical laboratory evaluations, vital signs, physical examinations, and other protocol-specified safety assessments.

Enrollment: 415 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants aged 6 years and older.
2. Clinical diagnosis of moderate to severe atopic dermatitis.
3. vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
4. EASI score ≥5 at baseline.
5. Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
6. Able and willing to comply with study procedures.
7. Participant or parent/legal guardian able to provide informed consent/assent.

Exclusion criteria

1. Uncontrolled medical conditions that could interfere with study participation.
2. Skin disorders that may confound study assessments.
3. Active infection requiring systemic treatment.
4. Known hypersensitivity to roflumilast or formulation components.
5. Use of prohibited medications within protocol-defined washout periods.
6. Pregnant or breastfeeding participants.
7. Participation in another interventional clinical trial within the protocol-defined timeframe.
8. Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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415 participants in 2 patient groups, including a placebo group

Vehicle Cream

Placebo Comparator group

Description:

Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period.

Treatment:

Drug: Vehicle Cream

Roflumilast Cream 0.3%

Experimental group

Description:

Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period.

Treatment:

Drug: Roflumilast Cream 0.3%